A hospital pharmacy can easily have several thousand
distinct pharmaceutical materials in inventory. Any of these materials
can enter the waste stream, and some must be managed as hazardous wastes. This
page will help you determine which rules apply.

The properties that make pharmaceuticals useful are the same
properties that make them hazardous. Pharmaceutical companies invest
billions of dollars every year to develop substances able to affect human metabolism
at very low concentrations. This potency does not change when a material
enters the waste stream.

Some pharmaceuticals must be extremely toxic in order to
function. Antineoplastic agents (the type of drug most often used in
chemotherapy), for example, are designed to kill dividing cells. Some radioactive
compounds are used for the same purpose.

A few drugs have other properties, unrelated to their intended
action, that makes them hazardous. Nitroglycerin, for example, which
causes blood vessels to dilate and can be used to treat chest pain, is also
well known for its explosive properties.

A relevant property of pharmaceuticals unrelated to their
function is their water solubility. In order to administer drugs in liquid
form, those that are not sufficiently soluble in water must be dissolved in
some kind of solvent, generally an alcohol-water mixture. This can pose
a flammability hazard, as discussed below.

Risks

A document available
from NIOSH contains detailed information on preventing workplace exposure
to chemotherapeutic drugs. The index page for the document also
provides a brief
summary, suitable for posting.

Pharmaceuticals in the waste stream can pose several
different types of risk. The most straightforward is that the active
ingredients in a discarded drug could act on an unintended target. But
other ingredients in pharmaceutical formulations can present hazards:

Preservatives and other ingredients can pose a toxicity
hazard over and above the effect of the main active ingredient

Some common solvents can pose a fire hazard (ignitability)

A few compounding agents are corrosive, including strong
acids with pH less than 2 (such as glacial acetic and carbolic acids) and
strong bases with pH greater than 12.5 (such as sodium hydroxide)

Some compounds are radioactive, including certain chemotherapy
drugs, and certain agents that are used as tracers or markers.

Risks from pharmaceuticals in healthcare facilities generally
cannot be eliminated by finding substitute materials, since the risk is often
inherent in the function. But the risks can be minimized and managed.

New
Hampshire DES provides several
detailed fact sheets on management and disposal of each type of
listed and characteristic pharmaceutical waste

Hazardous Determination

Your first task is to determine whether a given pharmaceutical
waste material must be treated as a hazardous
waste under RCRA. This section will help you through the federal
regulations. Please note that other requirements may apply in your state. For
information on state requirements, consult the HERC Hazardous
Waste State Locator.

The screening procedure recommended here is an elaboration
of the list provided on the HERC Hazardous
Waste Determination (HWD) page. We assume that you have already determined
that the waste you are screening meets the definition of "solid waste",
and that it not excluded by a regulatory exemption. In general, these
considerations are not likely to apply to pharmaceutical waste, but you may
want to check the HWD page for more background information.

Note also that pharmaceuticals that are being returned to
the manufacturer for credit are not considered to be wastes, according to an
EPA interpretation. (see below for more information
on "reverse distribution").

The screening procedure consists of answering the following
questions about the waste:

RCRA regulations provide several lists of materials that
are automatically considered hazardous wastes. If the materials you are
screening appears on these lists, your task is done -- the waste must be handled
as a hazardous waste. Refer to the HERC
Hazardous Waste Determination page for background information on the RCRA
lists.

However, there is one additional consideration. A peculiarity
of the RCRA framework is that it treats mixtures differently from single substances. If
the material in question is not the only active ingredient in the waste, you
will need to apply different criteria. The mixture might still have to
be treated as a hazardous waste if it has any of the hazardous waste characteristics
(see below). If not, a 1988
determination from EPA appears to indicate that a formulation with more
than one active ingredient might not fall within the RCRA definition of hazardous. This
is yet another indication that the RCRA framework needs some serious work. Experts
strongly recommend that in cases like this you treat these materials as if
they were RCRA hazardous wastes, if only as a matter of common sense.

Unused smoking cessation aids (e.g., patches and gum) that contain nicotine as the only ingredient are classified as listed hazardous waste P075. See EPA memo.

HERC has compiled tables listing
materials in each of the RCRA P-, U-,
and D-lists which may typically
be found in healthcare facility waste streams together with their typical uses. For
your convenience, a selection from the list covering pharmaceuticals specifically
is reproduced below. (This selection is based a table appearing in an article by
Charlotte Smith in the Journal of the Pharmacy Society of Wisconsin,
November-December, 2002. The article contains much useful background
information besides, and is recommended reading.)

Please note that these lists are not intended to be
complete. The full lists of all P- and U-listed wastes appear
in the Code of Federal Regulations, 40 CFR 261.33. (This
link will take you to the most recent available version of 40 CFR 261.33.)

Common P-Listed Pharmaceuticals:

Some states may regulate epinephrine salts more stringently than the federal regulations require. Check with your state environmental agency.

Name

No.

Arsenic trioxide

P012

Epinephrine1

P042

Nicotine

P075

Nitroglycerin2

P081

Physostigmine

P204

Physostigmine salicylate

P188

Warfarin >0.3%

P001

1 Does not include epinephrine salts.

2 A federal exemption for nitroglycerin,
in the form of finished dosages, was created in 2001, and has been adopted
by somestates.

Common U-Listed Pharmaceuticals:

Name

No.

Name

No.

Chloral Hydrate (CIV)2

U034

Mitomycin C (chemo)

U010

Chlorambucil (chemo)

U035

Paraldehyde (CIV)2

U182

Chloroform

U044

Phenacetin

U187

Cyclophosphamide (chemo)

U058

Phenol

U188

Daunomycin (chemo)

U059

Reserpine

U200

Dichlorodifluromethane

U075

Resorcinol

U201

Diethylstilbestrol

U089

Saccharin

U202

Formaldehyde

U122

Selenium sulfide

U205

Hexachlorophene

U132

Streptozotocin (chemo)

U206

Lindane

U129

Trichloromonofluromethane

U121

Melphalan (chemo)

U150

Uracil mustard (chemo)

U237

Mercury

U151

Warfarin <0.3%

U248

2 Chloral hydrate and paraldehyde are controlled
substances regulated by the
Drug Enforcement Administration and must be destroyed through a
"witnessed
destruction process". The article by
Charlotte Smith cited above points out that "their status as a RCRA hazardous
waste makes disposal very difficult."

Selected chemotherapy
agents by brand name

Many of the chemicals used to treat cancer patients during
chemotherapy fall on either the U or P lists. These agents are often
referred to by their brand names rather than the chemical designations appearing
on the lists. For your convenience, we have listed some common brand
names below, together with their chemical names and RCRA waste codes.

Since new products may be introduced at any time, this
list may not include all brand names composed of RCRA listed chemicals.

Brand name

Chemical Name

Code

Alkeran

Melphalan

U150

Cerubidine

Daunomycin

U059

CTX

Cyclophosphamide

U058

Cytotoxan

Cyclophosphamide

U058

Daunorubicin

Daunomycin

U059

DaunoXome

Daunomycin

U059

Leukeran

Chlorambucil

U035

Liposomal Daunorubicin

Daunomycin

U059

L-PAM

Melphalan

U150

Mitomycin

Mitomycin C

U010

Mutamycin

Mitomycin C

U010

Neosar

Cyclophosphamide

U058

Procytox

Cyclophosphamide

U058

Rubidomycin

Daunomycin

U059

Streptozocin

Streptozotocin

U206

Trisenox

Arsenic Trioxide

P012

Zanosar

Streptozotocin

U206

Note that while most chemotherapy agents are U-listed, arsenic
trioxide is P-listed.

In addition to these brand names, your facility may contain
various other listed drugs hat are used in cancer research or treatment, though
they have not been FDA-approved for general use. Examples include:

Azaserine U015

Chlornaphazin U026

Ethyl Carbamate U238

3-Methylchloranthrene U157

Other chemicals may be added to the RCRA lists at some point
in the future. In any case, even if some of the chemotherapy agents in
your facility are not currently included among the listed hazardous wastes,
they are of necessity extremely toxic, since their primary function is to kill
dividing cells. You may want to consider handling all chemotherapy agents
with the same level of care that is required for the listed hazardous wastes.

Characteristic Wastes

Making explicit lists is a good way to ensure that specific
materials are covered under the RCRA rules. But there are more potentially
dangerous materials in existence than any practical list could possibly contain. So
RCRA provides another way for a material to qualify as hazardous. Four characteristics,
or material properties, have been singled out as posing a particular risk of
damage to people or the environment. They are:

toxicity (D0xx, where xx represents
two digits from 04 through 43, and denotes a specific toxic chemical)

Each of these topics is related specifically to pharmaceutical
wastes in the discussion below. See the HERC
Hazardous Waste Determination page for a general discussion of RCRA characteristic
wastes.

Ignitability

Ignitability. Examples of ignitable wastes
include:

flammable liquids (flash point less than 60oC)

solids that can start burning through friction or absorption
of moisture

certain compressed gases

For pharmaceuticals, the presence of a flammable solvent
is the most typical reason that a particular formulation must be considered
ignitable. Mixtures of alcohol and water are often used in pharmaceutical
formulations. As it turns out, there is a special provision written into
the RCRA definition of ignitability, called the "alcohol exclusion", that
sets a threshold of 24% alcohol as a lower limit. That makes the determination
easy for alcohol-water mixtures: if it contains more than 24% alcohol,
it should be considered an ignitable hazardous waste. For other flammable
materials present in pharmaceutical formulations, such as aerosol propellants,
it is necessary to go through the actual test procedure for measuring the flash
point to make the determination. (It is a standard laboratory test.)

There are also a few strong oxidizers used in pharmaceuticals
formulations. Examples
include silver nitrate and potassium permanganate.

The regulations covering the ignitability characteristic
can be found in Title 40 of the Code of Federal Regulations, Part 261, Section
21 (40
CFR 261.21).

Corrosivity

This RCRA category refers to strong acids (pH less than 2)
and bases (pH greater than 12.5).

Only a few examples of this type of waste are likely to be
found associated with pharmaceuticals. Glacial acetic acid and concentrated
sodium hydroxide may sometimes be used in compounding off-the-shelf pharmaceuticals
for custom uses. Either of these materials would be considered as corrosive
hazardous wastes.

The regulations covering the corrosivity characteristic can
be found in Title 40 of the Code of Federal Regulations, Part 261, Section
22 (40
CFR 261.22).

Reactivity

A waste is reactive in the RCRA sense if it is liable to
explode, or to react violently or release toxic gases if it comes in contact
with water.

The only pharmaceutical that would fall under this definition
is nitroglycerin (which is also a P-listed material). But healthcare
facilities do not typically deal with the bulk form, and when packaged into
individual doses, nitroglycerin is not explosive. According to a relatively
recent (2001) ruling by the EPA, if a waste contains a P or U listed material
in a form in which it does not exhibit its characteristic property, it does
not have to be regarded as hazardous. Nitroglycerin in dosage form falls
under this ruling, and thus does not have to be treated as hazardous.

D-Listed Chemicals Found in Pharmaceuticals (with threshold
levels):

This
link will take you to the most recent available version of the complete
D-list.

Disposal of hazardous pharmaceutical wastes

The best pollution prevention alternative, elimination or
substitution of hazardous materials, is typically not an option for pharmaceuticals,
since their hazards and their functionality are two sides of the same coin.

But for pharmaceuticals, there is an alternative that is
not available for most other hazardous substances. "Reverse distribution" is
a process whereby some unused, but potentially usable pharmaceuticals can be
returned to the manufacturer for credit. To facilitate this process,
EPA has determined that healthcare facilities do not have to consider returned
pharmaceuticals as "discarded materials". This removes the
burden of having to treat them as hazardous wastes (or, more properly, shifts
the burden to the reverse distributor). In particular, facilities do not have
to use a hazardous waste hauler or fill out manifests to ship returns, or to
count returns in determining their hazardous
waste generator status.

It is important to recognize that the exclusion applies only
to bona fide returns for credit, and not to broken containers, spilled contents,
compounding leftovers, or similar cases. It is also important to deal
with reverse distributors who are themselves in compliance.